INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRAND
About this trial
Low medication adherence when initiating antiretroviral treatment (ART) is a key barrier to HIV virologic suppression, resulting in avoidable cases of drug resistance, death, and viral transmission. Routinized pill-taking can lead to successful long-term ART adherence, and short-term behavioral economics-based supports are a novel way to overcome the limited success of existing routinization interventions. This study proposes to test this combined approach for promoting long-term ART adherence using a Stage III Sequential, Multiple Assignment, Randomized Trial (SMART) design in one of the largest HIV clinics in Uganda to identify the most cost-effective adaptive intervention that if found effective is generalizable to other settings and other chronic diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female clients age 18 and older.
Started ART at Mildmay or another clinic within the preceding 2 months
Able to speak and understand either English or Luganda.
Have their own cell phone or have consistent access to someone else's phone.
Disqualifiers
Not mentally fit to consent.
Language other than Luganda or English.
Not willing to consistently use the Wisepill device for adherence measurement.
Trial design
Design model
Sequential
Treatments tested in this trial
Daily Text Messages
BehavioralParticipants will receive daily text message reminders to use their routine behavior to trigger medication adherence.
Incentivization based on timely ART adherence
BehavioralParticipants will be eligible to (draw a prize in monthly prize group) or get a monthly prize (monthly escalated group) if they take their medication within +/-one hour of the stated existing routine to which pill-taking is anchored on at least 80% of days for 3-months.
Treatment groups
550 Participants
are divided into 4 treatment groupsGroup A: Phase B Stage 1: ControlNo intervention 0 interventions
Group B: Phase B Stage 1: Intervention group receiving messages (Messages group)Experimental treatment 1 intervention
Group C: Phase B Stage 2: Intervention group receiving messages and incentives (Monthly prize draws)Experimental treatment 2 interventions
Group D: Phase B Stage 2: Intervention group receiving messages and incentives (Monthly escalated Prizes)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Electronically measured mean medication adherence
We will collect Wisepill data continuously over the 24-month study period to calculate the primary outcome variable of mean adherence (# of actual bottle openings /# of prescribed bottle openings)
Time frame
24 monthsSecondary outcomes
1
Retention in Care.
Retention in care will be measured as the fraction of participants recruited who are still active clients at the clinic at month 24.
Time frame
24 months2
Viral Suppression
HIV RNA (viral load) is the secondary outcome measure, and we will also examine intervention effects on mean change in log-transformed viral load. Viral loads are now part of routine clinical care in Uganda and will be chart abstracted.
Time frame
24 months3
Routinization of ART adherence
We will calculate the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking.
Time frame
24 monthsSponsors and contacts
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RAND
Lead sponsor
Arizona State University
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Mildmay Uganda Limited
Collaborator
Source ClinicalTrials.gov